510(k) K081412 ยท FRN Pump, Infusion
PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Dec 17, 2008 |
| Received | May 20, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081412
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 6, 2016 | Hospira Inc. Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectr Terminated |
FRN | None listed |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump. List Number 11971. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic Terminated |
FRN | None listed |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinic Terminated |
FRN | None listed |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump. List Number 12391. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini Terminated |
FRN | None listed |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20679. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t Terminated |
FRN | None listed |
| Sep 6, 2016 | Hospira Inc. Plum A+ Infusion Pump with Hospira MedNet Software. List Number 20792. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across t Terminated |
FRN | None listed |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump System. List Number 12348. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum o Terminated |
FRN | None listed |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump. List Number 12618. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clini Terminated |
FRN | None listed |
| Sep 6, 2016 | Hospira Inc. Plum A+3 Infusion Pump with Hospira MedNet Software. List Number 20678. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across Terminated |
FRN | None listed |
| Feb 23, 2015 | Hospira Inc. The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows t Terminated |
FRN | None listed |
| Nov 14, 2013 | Hospira Inc. Plum A+ Hyperbaric Infusion Pump;
List Number 11005;
Labeled in part: PLUM A+ HYPERBARIC;
Product Usage:
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise d Terminated |
FRN | None listed |
| Nov 14, 2013 | Hospira Inc. The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Terminated |
FRN | None listed |
| Dec 31, 2012 | Hospira Inc. Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric t Terminated |
FRN | None listed |
| Dec 7, 2012 | Hospira Inc. Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNe Terminated |
FRN | None listed |
| Oct 4, 2011 | Hospira Inc. Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005
Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric ther Terminated |
FRN | None listed |
| Sep 29, 2011 | Hospira Inc. Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005.
Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion P Terminated |
FRN | None listed |
| Mar 14, 2011 | Hospira Inc. Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list 11005
The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace a Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.